127
Participants
Start Date
December 31, 2012
Primary Completion Date
April 30, 2014
Study Completion Date
April 30, 2014
APOKYN
"Apokyn will be titrated to an optimum dose which reproduces 90% of the subjects' best on UPDRS score during the Initiation Period. During the APOKYN Treatment Period, subjects will inject the dose identified in the initiation period once daily at the time of their normal scheduled L-Dopa dose (L-Dopa will be delayed by 40 minutes)."
L-dopa
Subjects on a stable L-Dopa regimen will be entered into the study. For the L-Dopa Baseline Period through the Initiation Period, subjects will continue their normal L-Dopa dosing regimen. During the APOKYN Treatment Period, subjects will replace their normally scheduled first morning L-Dopa dose with an APOKYN injection, and then administer their normal first morning L-Dopa dose 40 minutes later.
Trimethobenzamide
Following the L-Dopa Baseline Period, subjects will initiate trimethobenzamide treatment TID for a minimum of 3 days during a Anti-Emetic Pretreatment Period. Subjects will continue trimethobenzamide therapy TID through the duration of the APOKYN Initiation Period and APOKYN Treatment Period.
Parkinson's Disease and Movement Disorders Center of New York, Commack
Georgetown University, Washington D.C.
Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton
University Hospitals Case Medical Center, Cleveland
University of Cincinnati Academic Health Center, Cincinnati
Henry Ford West Bloomfield Hospital, Bloomfield Hills
Rush University Medical Center, Chicago
The Movement Disorder Clinic of Oklahoma, Tulsa
University of Texas Health Science Center, Houston, Department of Neurology, Houston
Center for Neurological Care and Research, San Antonio
Keck School of Medicine, Los Angeles
Neurosearch, Inc., Reseda
MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
INDUSTRY